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Northwind Pharmaceuticals Recalls
13 recalls on record · December 9, 2015 to September 24, 2025 · Drugs
Recalls by year
15
18
23
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 24, 2025DrugsFDA
Northwind Pharmaceuticals LLC recalls Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-3
Hazard: Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
May 3, 2023DrugsFDA
Northwind Pharmaceuticals LLC recalls Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203
Hazard: CGMP Deviations
May 3, 2023DrugsFDA
Northwind Pharmaceuticals LLC recalls Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC 51655-473-
Hazard: CGMP Deviations
May 3, 2023DrugsFDA
Northwind Pharmaceuticals LLC recalls Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-52), and b) 90-count bottles (NDC 51655-120
Hazard: CGMP Deviations
May 3, 2023DrugsFDA
Northwind Pharmaceuticals LLC recalls Glimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-52), and b)90-count bottles (NDC 51655-383-
Hazard: CGMP Deviations
May 3, 2023DrugsFDA
Northwind Pharmaceuticals LLC recalls Doxazosin Tablets, USP, 4mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203
Hazard: CGMP Deviations
May 3, 2023DrugsFDA
Northwind Pharmaceuticals LLC recalls BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repackaged By: NOrthwind Pharmaceuticals, Indian
Hazard: CGMP Deviations
May 3, 2023DrugsFDA
Northwind Pharmaceuticals LLC recalls Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapo
Hazard: CGMP Deviations
August 22, 2018DrugsFDA
Northwind Pharmaceuticals LLC recalls Valsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC:
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 22, 2018DrugsFDA
Northwind Pharmaceuticals LLC recalls Valsartan, 80mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC:
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 22, 2018DrugsFDA
Northwind Pharmaceuticals LLC recalls Valsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 4
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 22, 2018DrugsFDA
Northwind Pharmaceuticals LLC recalls Valsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
December 9, 2015DrugsFDA
Northwind Pharmaceuticals LLC recalls Prednisone 20 mg, Tablet, 10-count bottle, Rx only, Mfg by: HIKMA Pharmaceuticals PO BOX 182400 Amman 11118 Jordan. Dist
Hazard: Labeling: Not elsewhere classified. NDC number is incorrect on the container.